Hereditary
Cancer Testing

Help Your Patients’ Family Members Better Understand their Risk of Developing Cancer

Knowing your patient’s hereditary cancer risk is critical when it comes to making treatment decisions. Blending both their genetic test status and family history of cancer, the Myriad myRisk® hereditary cancer panel represents the next generation of hereditary cancer risk testing. Myriad myRisk is here to help you determine the right treatment for your patients with a report including comprehensive results and a guideline-based Medical Management Tool.

Learn More About the Myriad myRisk Test

Offer Accurate and Comprehensive Risk Assessment in Your Practice with myRisk® and riskScore®

myRisk genetic testing

The Myriad myRisk® Hereditary Cancer multi-gene panel analyzes risk for 8 cancers of focus to determine if your patient has a germline genetic mutation associated with an increased cancer risk. Receive test results in 14 days or less.

riskScore breast cancer screening

riskScore® is a clinically validated tool which uses genetic markers and clinical risk factors to predict a 5-year and remaining lifetime risk of developing breast cancer.*

Faster Results for Patients with Pancreatic Cancer to Inform Treatment

BRCA1/2, PALB2 and 8 other genes reported in 5-12 calendar days**†
Full Myriad myRisk report in 14 calendar days or less

Sources:
*riskScore is calculated for women of solely European ancestry under the age of 85 without a personal history of breast cancer, LCIS, hyperplaysia, atypical hyperplasia, or a breast biopsy of unknown results. riskScore is not calculated if a woman or a blood relative is known to carry a mutation in a breast cancer risk gene.1-4

  1. Mavaddat N, et al. Prediction of breast cancer risk based on profiling with common genetic variants. J Natl Cancer Inst. 2015 Apr 8;107(5). PubMed.
  2. Michailidou K, et al. Large-scale genotyping identifies 41 new loci associated with breast cancer risk. Nat Genet. 2013 Apr;45(4):
    353-61.
  3. Michailidou K, et al. Genome-wide association analysis of more than 120,000 individuals identifies 15 new susceptibility loci for
    breast cancer. Nat Genet. 2015 Apr;47(4):373-80. PubMed.
  4. Tyrer J, et al. A breast cancer prediction model incorporating familial and
    personal risk factors. Stat Med. 2004 23:1111-30.

**The 11 breast cancer genes in the preliminary report are BRCA1, BRCA2, TP53, STK11, CDH1, PTEN, PALB2, ATM, CHEK2, NBN and BARD1.
†Patients with government payers (Medicare, Medicare Advantage, TriCare) are not eligible for myRisk STAT

Intended Use
PMA Intended Use Statement for BRACAnalysis CDx

BRACAnalysis CDx® is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.

Results of the test are used as an aid in identifying patients who are or may become eligible for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.

Table 1: Companion diagnostic indications

Tumor TypeBiomarkerTherapy
Breast CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)
Talzenna® (talazoparib)
Ovarian CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)-
treatment/maintenance
Rubraca® (rucaparib)
Pancreatic CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)
Prostate CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)

Detection of deleterious or suspected deleterious germline BRCA1 and BRCA2 mutations by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula® (niraparib) or Rubraca® (rucaparib) maintenance therapy.

This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108

Limitation: In Ovarian Cancer, ~70% of tumor BRCA1 or BRCA2 mutation positive patients are estimated to have a germline mutation while ~30% of patients are estimated to have a somatic mutation. The BRACAnalysis CDx test detects germline mutations only, not somatic mutations from a patient’s blood sample. A negative result using the BRACAnalysis CDx blood test in ovarian cancer patients does not rule out the possibility of a somatic BRCA1 or BRCA2 mutation in tumor tissue from these patients.

Limitation: In Prostate Cancer, ~50% of tumor BRCA1 or BRCA2 mutation positive patients are estimated to have a germline mutation while ~50% of patients are estimated to have a somatic mutation. The BRACAnalysis CDx test detects germline mutations only, not somatic mutations from patient’s blood sample. A negative result using the BRACAnalysis CDx blood test in prostate cancer patients does not rule out the possibility of a somatic BRCA1 or BRCA2 mutation in tumor tissue from these patients.